INTENT Pilot Study - Enhancing Adherence Intentions to Endocrine Therapy

Not Applicable

Completed

• Conditions: Breast Cancer; Breast Cancer Female; Breast Carcinoma
• Interventions: Behavioral: Endocrine Therapy Education Program

• Registration Number: NCT06246084
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

This research is being done to pilot an intervention which aims to improve participants' experiences on Endocrine Therapy.

The name of the intervention used in this research study is:

Endocrine Therapy Education Program (a brief, video-based intervention)

Detailed Description

This research study is a randomized pilot study to determine whether a brief-video based intervention program can improve experiences of Endocrine Therapy (ET). Participants will be randomized into one of two groups: Group A: Endocrine Therapy Education Intervention vs. Group B Wait-list Control Group. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, in-clinic visits, and survey questionnaires.

Participation in this research study is expected to last 3 months.

It is expected that about 60 people will take part in this research study.

Study Timeline

• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-02-07
• Study Start: 2024-02-15
• Primary Completion: 2024-07-31
• Status Verified: 2024-09
• Study Completion: 2024-12-23
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

• Biologically female
• About to begin or just started (within four weeks of starting) an oral form of ET (either tamoxifen or AI)
• 18 years of age or older
• English fluency for reading and writing.
• Computer literacy (ability to watch videos and fill out questionnaires online)

Exclusion Criteria

• Adults unable to consent
• Individuals with metastatic cancer
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Endocrine Therapy Education Intervention	Endocrine Therapy Education Program	Participants will complete: * Baseline visit. * Educational video once a week for 6 weeks. * 6-week survey. * 3-month survey.

Primary Outcome Measures

Name	Time	Method
Engagement Rate of Intervention	6 weeks	Adequate engagement of the intervention is defined as a click-to-open rate of 60% or over for the intervention group.
Intervention Satisfaction Questionnaire Mean Score Group A	At 6 weeks	Responses will be analyzed to determine a mean score for each item for the intervention group. The Intervention Satisfaction Questionnaire includes 9 items rated on a 1 to 10 scale.
Intervention Satisfaction Questionnaire Mean Score Group B	At 14 weeks	Responses will be analyzed to determine a mean score for each item for the control group (following the release of the intervention educational videos). The Intervention Satisfaction Questionnaire includes 9 items rated on a 1 to 10 scale.

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States